TY - JOUR
T1 - Out of the black box
T2 - Treatment of resistant depression in adolescents and the antidepressant controversy
AU - Wagner, Karen Dineen
AU - Asarnow, Joan Rosenbaum
AU - Vitiello, Benedetto
AU - Clarke, Gregory
AU - Keller, Martin
AU - Emslie, Graham J.
AU - Ryan, Neal
AU - Porta, Giovanna
AU - Iyengar, Satish
AU - Ritz, Louise
AU - Zelanzny, Jamie
AU - Onorato, Matthew
AU - Brent, David
PY - 2012/2/1
Y1 - 2012/2/1
N2 - Objective: The purpose of this article is to describe the effects of the pediatric antidepressant controversy on the Treatment of Serotonin-Selective Reuptake Inhibitor (SSRI) Resistant Depression in Adolescents (TORDIA) trial. Method: Adolescents, ages 12-18 years, with SSRI resistant depression were randomized to one of four treatments for a 12 week trial: Switch to different SSRI, switch to an alternate antidepressant (venlafaxine), switch to an alternate SSRI plus cognitive behavior therapy (CBT), or switch to venlafaxine plus CBT. Results: The health advisories and "black box" warnings regarding suicidality and antidepressants in adolescents occurred during the course of the TORDIA trial. Revisions to the protocol, multiple-consent form changes, and re-consenting of patients were necessary. Recruitment of participants was adversely affected. Conclusion: Despite a cascade of unforeseen events that delayed the completion of the study, the TORDIA trial resulted in clinically important information about treatment-resistant depression in adolescents.
AB - Objective: The purpose of this article is to describe the effects of the pediatric antidepressant controversy on the Treatment of Serotonin-Selective Reuptake Inhibitor (SSRI) Resistant Depression in Adolescents (TORDIA) trial. Method: Adolescents, ages 12-18 years, with SSRI resistant depression were randomized to one of four treatments for a 12 week trial: Switch to different SSRI, switch to an alternate antidepressant (venlafaxine), switch to an alternate SSRI plus cognitive behavior therapy (CBT), or switch to venlafaxine plus CBT. Results: The health advisories and "black box" warnings regarding suicidality and antidepressants in adolescents occurred during the course of the TORDIA trial. Revisions to the protocol, multiple-consent form changes, and re-consenting of patients were necessary. Recruitment of participants was adversely affected. Conclusion: Despite a cascade of unforeseen events that delayed the completion of the study, the TORDIA trial resulted in clinically important information about treatment-resistant depression in adolescents.
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U2 - 10.1089/cap.2011.0045
DO - 10.1089/cap.2011.0045
M3 - Article
C2 - 22251022
SN - 1044-5463
VL - 22
SP - 5
EP - 10
JO - Journal of Child and Adolescent Psychopharmacology
JF - Journal of Child and Adolescent Psychopharmacology
IS - 1
ER -